Intraoperative Electronic Reminder Module to Enhance Postoperative Nausea and Vomiting Prophylaxis
Primary Purpose
Postoperative Nausea and Vomiting
Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Postoperative nausea and vomiting (PONV) reminder
Sponsored by
About this trial
This is an interventional prevention trial for Postoperative Nausea and Vomiting
Eligibility Criteria
Inclusion Criteria:
- Age ≥ 18 years
- Procedure with General Anesthesia
Exclusion Criteria:
- Postoperative admission to the Intensive Care Unit
- Postoperative fast-track to Phase II
- Patient remains sedated/intubated at the end of the procedure
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
PONV Reminder
No PONV Reminder
Arm Description
After patient has non-cardiac surgery, the subject will have Post-Operative Nausea and Vomiting Reminder display
After patient has non-cardiac surgery, the subject will not have Post-Operative Nausea and Vomiting Reminder display
Outcomes
Primary Outcome Measures
Incidence of postoperative nausea and vomiting
Incidence of postoperative nausea and vomiting in the recovery room
Secondary Outcome Measures
Duration of postoperative anesthesia care unit (PACU) stay
Time to postoperative anesthesia care unit (PACU) discharge alive (hours)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02830412
Brief Title
Intraoperative Electronic Reminder Module to Enhance Postoperative Nausea and Vomiting Prophylaxis
Official Title
A Prospective Randomized Evaluation of an Intraoperative Electronic Reminder Module to Enhance Postoperative Nausea and Vomiting Prophylaxis Guideline Adherence
Study Type
Interventional
2. Study Status
Record Verification Date
August 2017
Overall Recruitment Status
Withdrawn
Why Stopped
No patients enrolled
Study Start Date
November 2016 (Actual)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Cleveland Clinic
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This project intends to develop and implement an electronic reminder for post-operative nausea and vomiting (PONV) prophylaxis into the Anesthesia Record Keeping System.
Each patient will have his or her PONV risk classified based on the following risk factors: Female gender, History of PONV, History of Motion Sickness, Non-smoker and Duration of procedure > 60 minutes.
Patients will be randomized to either receive the PONV reminder or not. Those receiving the PONV reminder will have the PONV risk assessment and current guideline information for PONV prophylaxis displayed on the Anesthesia Record Keeping System (ARKS) screen at the beginning of the case.
At the end of the procedure (specific at documentation of emergence), the reminder will assess the current status of PONV prophylaxis as per anti-emetic medications administered and compare the current status to the recommended status based on published guidelines.
If the current status is compatible or exceeds the recommended status the reminder will silently document compliance.
If published guidelines suggest additional PONV prophylaxis based on the patients risk profile and a comparison with the currently documented status, an electronic reminder will appear on the ARKS screen to alert the anesthesia provider of an opportunity to enhance guideline adherence.
The reminder will not recommend a specific medication, intervention or therapy.
It will be completely the decision of the anesthesia provider if and how to modify the PONV prophylaxis for the patient.
Subjects randomized to not receive the electronic display will have it deactivated.
Detailed Description
Each patient will have his or her PONV risk classified based on the following risk factors Female gender, History of PONV or Motion Sickness, Non-smoker and Duration of procedure > 60 min utilizing information already entered into the Anesthesia Record Keeping System. Patients having 0-1 risks factors present will be low risk. 2 risks factors present are medium risk and more than 2 risk factors present are high risk.
Patients will be randomized to either receive the PONV reminder or not. Those receiving the PONV reminder will have the PONV risk assessment and current guideline information for PONV prophylaxis will be displayed on the ARKS screen at the beginning of the case.
In a second step at the end of the procedure (specific at documentation of emergence), the reminder will assess the current status of PONV prophylaxis as per anti-emetic medications administered and compare the current status to the recommended status based on published guidelines.
If the current status is compatible or exceeds the recommended status the reminder will silently document compliance.
If published guidelines suggest additional PONV prophylaxis based on the patients risk profile and a comparison with the currently documented status, an electronic reminder will appear on the ARKS screen to alert the anesthesia provider of an opportunity to enhance guideline adherence.
The reminder will display the PONV risk assessment information, current status of PONV prophylaxis as well as the information that current guidelines recommend additional PONV prophylaxis.
The reminder will not recommend a specific medication, intervention or therapy.
It will be completely the decision of the anesthesia provider if and how to modify the PONV prophylaxis for the patient.
Subjects randomized to not receive the electronic display will have it deactivated.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Nausea and Vomiting
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PONV Reminder
Arm Type
Experimental
Arm Description
After patient has non-cardiac surgery, the subject will have Post-Operative Nausea and Vomiting Reminder display
Arm Title
No PONV Reminder
Arm Type
No Intervention
Arm Description
After patient has non-cardiac surgery, the subject will not have Post-Operative Nausea and Vomiting Reminder display
Intervention Type
Other
Intervention Name(s)
Postoperative nausea and vomiting (PONV) reminder
Intervention Description
The postoperative nausea and vomiting (PONV) electronic reminder will be programmed to assess the patient risk for PONV according to the risk factors identified by Apfel and Koivuranta. The PONV risk assessment and current guidelines will be displayed electronically for patients randomized to receive the reminder.
Primary Outcome Measure Information:
Title
Incidence of postoperative nausea and vomiting
Description
Incidence of postoperative nausea and vomiting in the recovery room
Time Frame
6 hours
Secondary Outcome Measure Information:
Title
Duration of postoperative anesthesia care unit (PACU) stay
Description
Time to postoperative anesthesia care unit (PACU) discharge alive (hours)
Time Frame
6 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age ≥ 18 years
Procedure with General Anesthesia
Exclusion Criteria:
Postoperative admission to the Intensive Care Unit
Postoperative fast-track to Phase II
Patient remains sedated/intubated at the end of the procedure
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Saager leif, M.D.
Organizational Affiliation
The Cleveland Clinic
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Intraoperative Electronic Reminder Module to Enhance Postoperative Nausea and Vomiting Prophylaxis
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